Why it was recalled
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Product description
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
Lot numbers, UPCs & expiration codes
Lot# 5A17A, Expiry 06/16 Lot# 5K21A, Expiry 03/17 Lot# 6A08A, Expiry 06/17
Where it was sold
Nationwide and Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0949-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 17, 2016
- FDA report date
- Jun 8, 2016
- Quantity
- 57,920 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0949-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 74099
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot# 5A17A, Expiry 06/16 Lot# 5K21A, Expiry 03/17 Lot# 6A08A, Expiry 06/17
- Postal code
- 60045-4862
- Report date
- Jun 8, 2016
- Product type
- Drugs
- Recall number
- D-0949-2016
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 57,920 bottles
- Termination date
- Jul 21, 2017
- Reason for recall
- Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- May 17, 2016
- Initial firm notification
- Letter
- Center classification date
- May 29, 2016